Massachusetts General Hospital Evaluation of DePuy ASR Hip System

Status unconfirmed

Conditions studied: Osteoarthritis

In brief

DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a higher than expected revision rate reported in the England/Wales and Australian national joint registries. There are two types of ASR hip implants used for total hip replacement surgery: * ASR XL Hip System * ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the study sponsor. MGH is conducting this study with the help of funding from DePuy Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects around the world. The countries include the United States of America, Australia, South Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will analyze the data annually for 6 years. The purpose of this study is to follow patients who have the ASR hip system for the next 6 years. The findings of this study may help surgeons to make better informed decisions about monitoring and treatment of patients with ASR hip systems.

Key facts

Study ID

NCT01611233

Run by

Massachusetts General Hospital

People needed

1950

Starts

2012-09-01

Expected to finish

2022-12-01

Last updated by the study team

2021-01-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient with on-label use of the ASR-XL or ASR component system currently implanted.
• Able to provide informed consent previously approved by institution's Institutional Review board (IRB) or ethics committee (EC).
• Able to return for follow-up.
• Able to complete the required patient reported outcome measures.

You may not qualify if…

• Any patient with off-label use indications for the ASR-XL or ASR component system.
• Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.
• Subjects with difficulty in comprehending the Informed Consent Form for any reason.
• The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.

Where it is running

• Northshore University HealthSystem, Glenbrook Hospital — Glenview, Illinois, United States
• Summit Orthopedics — Woodbury, Minnesota, United States
• Syracuse Orthopedic Specialists — Syracuse, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Texas Hip and Knee Center — Fort Worth, Texas, United States
• Sportsmed Sa — Stepney, South Australia, Australia
• Istituti Ospedalieri Bresciani S.p.A. — Brescia, Italy
• Morningside Medi-Clinic — Bryanston, South Africa
• Cape Hip and Knee Practice — Cape Town, South Africa
• Westville Hospital — Durban, South Africa
• Royal Berkshire Hospital — Reading, Berkshire, United Kingdom
• Rotherham NHS Foundation Trust, Rotherham Hospital — Rotherham, United Kingdom
• Sheffield Teaching Hospitals Foundation Trust — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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